U.S. patent application number 12/510145 was filed with the patent office on 2010-07-29 for penetrating member with direct visualization.
Invention is credited to Singfatt Chin, Lex P. JANSEN, John T. To.
Application Number | 20100191057 12/510145 |
Document ID | / |
Family ID | 41610684 |
Filed Date | 2010-07-29 |
United States Patent
Application |
20100191057 |
Kind Code |
A1 |
JANSEN; Lex P. ; et
al. |
July 29, 2010 |
PENETRATING MEMBER WITH DIRECT VISUALIZATION
Abstract
Systems and methods for accessing the spine include tissue
penetrating members with direct visualization capability that may
be used to form an access pathway to a targeted treatment site. The
direct visualization capability, which may be provided by
fiberoptic illumination and imaging components, may be use to
visualize the tissue as the access pathway is formed by the tissue
penetrating member. The tissue penetrating members include
catheters and cannulas with sharpened tips with integrated
fiberoptic components and/or channels in which a fiberscope or
miniscope may be inserted. Apertures and/or transparent materials
are provided to permit imaging of tissue about the distal end of
the tissue penetrating member.
Inventors: |
JANSEN; Lex P.; (Pleasanton,
CA) ; Chin; Singfatt; (Pleasanton, CA) ; To;
John T.; (Newark, CA) |
Correspondence
Address: |
MORRISON & FOERSTER LLP
755 PAGE MILL RD
PALO ALTO
CA
94304-1018
US
|
Family ID: |
41610684 |
Appl. No.: |
12/510145 |
Filed: |
July 27, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61084202 |
Jul 28, 2008 |
|
|
|
Current U.S.
Class: |
600/127 ;
128/898 |
Current CPC
Class: |
A61B 1/3135 20130101;
A61B 17/3211 20130101; A61B 17/3478 20130101; A61B 1/00082
20130101; A61B 90/361 20160201; A61B 1/3137 20130101; A61B 1/00096
20130101; A61B 17/320016 20130101; A61B 17/3401 20130101; A61B
1/00087 20130101; A61B 2017/3454 20130101; A61B 1/0051
20130101 |
Class at
Publication: |
600/127 ;
128/898 |
International
Class: |
A61B 17/34 20060101
A61B017/34; A61M 29/00 20060101 A61M029/00; A61B 1/04 20060101
A61B001/04 |
Claims
1. A method for accessing an epidural space of a patient,
comprising: penetrating intact body tissue using a first flexible
fiberscope removably located in a longitudinal lumen of a rigid
tubular member with a distal penetrating tip and at least one
viewing aperture located about the distal penetrating tip; forming
a tissue pathway with the distal penetrating tip through the intact
body tissue and toward an epidural space of a patient; visualizing
the tissue pathway using the first flexible fiberscope while
forming at least a portion of the tissue pathway; removing the
flexible fiberscope from the rigid tubular member; passing and
withdrawing a dilator over the rigid tubular member; inserting an
introducer over the rigid tubular member; removing the rigid
tubular member from the introducer; inserting a second flexible
fiberscope into a steerable multi-lumen cannula; inserting the
steerable multi-lumen cannula through the introducer; and
visualizing an epidural space using the second flexible
fiberscope.
2. The method of claim 1, wherein the first flexible fiberscope and
the second flexible fiberscope are the same fiberscope.
3. The method of claim 1, wherein inserting the second flexible
fiberscope into a steerable multi-lumen cannula is performed before
inserting the steerable multi-lumen cannula through the
introducer.
4. The method of claim 1, further comprising rotating the first
flexible fiberscope within the lumen of the rigid tubular
member.
5. The method of claim 1, further comprising adjusting the
formation of the pathway by reorientating the distal penetrating
tip toward the spine region.
6. The method of claim 1, further comprising visualizing the tissue
pathway using the second flexible fiberscope while inserting the
steerable multi-lumen cannula through the introducer.
7. The method of claim 6, wherein visualizing the tissue pathway
using the second flexible fiberscope comprising visualizing the
tissue pathway through a wall of the introducer, wherein at least a
portion of the wall comprises an optically transparent
material.
8. The method of claim 1, further comprising inserting the first
flexible fiberscope into the rigid tubular member.
9. The method of claim 1, wherein visualizing the tissue pathway
using the first flexible fiberscope comprises visualizing the
tissue pathway through an optically transparent structure located
at a viewing aperture.
10. The method of claim 1, further comprising: positioning the
distal penetrating tip of the rigid cannula member at a
postero-lateral location of the patient about 8 cm to about 20 cm
lateral to the midsaggital plane of the patient; and orienting the
rigid cannula member at an angle of about 20 degrees to about 50
degrees to the midsaggital plane.
11. A method for accessing a body region of a patient, comprising:
piercing unpierced body tissue of a patient using a piercing member
comprising an illumination assembly and a direct visualization
assembly; and forming a tissue pathway through unpierced body
tissue toward a target body site; and visualizing the tissue
pathway using the direct visualization assembly while at least a
portion of the tissue pathway is being formed through the unpierced
body tissue.
12. The method of claim 11, wherein the unpierced body tissue is
about 8 to about 20 cm lateral to a posterior spinous process of a
vertebra.
13. The method of claim 11, further comprising orienting the
piercing member at an angle of about 20 degrees to about 50 degrees
to the midsaggital plane of the patient.
14. The method of claim 11, wherein the piercing member is a
beveled piercing member.
15. The method of claim 11, wherein the tissue pathway passes
through at least the sacrospinalis, quadratus lumborum and the
psoas major muscles.
16. The method of claim 11, wherein the tissue pathway passes
between the iliocostalis muscle and the thoraco-lumbar fascia at
least the sacrospinalis, quadratus lumborum and the psoas major
muscles.
17. The method of claim 11, further comprising actuating a steering
controller of the piercing member to form a non-linear tissue
pathway toward the spine.
18. The method of claim 11, further comprising flushing fluid
through the piercing member before reaching the target body
site.
19. The method of claim 11, further comprising confirming the
position of the tissue penetrating distal tip radiographically.
20. The method of claim 11, further comprising piercing through a
longissimus muscle of a patient.
21. The method of claim 11, further comprising piercing through a
multifidus muscle of a patient.
22. The method of claim 11, further comprising forming a tissue
pathway between a longissimus muscle and an adjacent multifidus
muscle of a patient.
23. The method of claim 11, further comprising: removing the
illumination assembly and the direct visualization assembly from
the piercing member; passing a first guide element into the patient
using the piercing member; and removing the piercing member while
maintaining the first guide element in the patient.
24. The method of claim 23, wherein removing the illumination
assembly and the direct visualization assembly from the piercing
member comprises removing a fiberscope in which the illumination
assembly and the direct visualization assembly are integrally
formed.
25. The method of claim 11, wherein the target body site is a blood
vessel.
26. The method of claim 11, wherein the target body site is an
epidural space of a spine.
27. The method of claim 11, wherein the target body site is
selected from a group consisting of a breast mass, a liver mass, a
pericardial sac, a kidney mass, a lung nodule, a lymph node, an
ascites fluid collection, and a pleural fluid collection.
28. The method of claim 23, wherein passing the first guide element
into the patient using the piercing member comprises inserting a
guidewire into the patient through the piercing member.
29. The method of claim 23, further comprising passing a second
guide element into the patient using the first guide element and
removing the first guide element from the second guide element.
30. The method of claim 24, further comprising: inserting the
direct visualization assembly into a lumen member; and inserting
the lumen member into the patient.
31. A system for performing an access procedure, comprising: a
miniscope, comprising: a video connector located about a proximal
end; a lens located about a distal end; a flexible shaft segment
comprising at least one illumination optic fiber and at least one
viewing optic fiber and having a longitudinal length of at least
about 3 inches and an average axial cross-sectional area of less
than about 1.2 mm.sup.2; an elongate piercing member, comprising: a
distal penetrating tip; a miniscope receiving opening; shaft
segment located between the distal penetrating tip and the
miniscope receiving opening, the shaft segment comprising a
miniscope lumen in communication with the proximal miniscope
receiving opening and having a longitudinal length of at least
about 3 inches an average axial cross-sectional lumen area of less
than about 1.3 mm.sup.2, and comprising at least one distal viewing
window.
32. The system of claim 31, wherein the miniscope is pre-inserted
into the elongate piercing member.
33. The system of claim 31, wherein the distal penetrating tip
comprises a conical configuration.
34. The system of claim 31, wherein the distal penetrating tip
comprises at least one cutting edge.
35. The system of claim 31, wherein the distal penetrating tip
comprises a flat blade structure.
36. The system of claim 31, wherein at least one viewing window
comprises a viewing opening.
37. The system of claim 31, wherein at least one viewing window
comprises an optically transparent material.
38. The system of claim 31, wherein the distal penetrating tip
comprises an optically transparent material.
39. The system of claim 31, wherein the shaft segment of the
elongate piercing member is a multi-lumen shaft segment.
40. The system of claim 39, wherein the multi-lumen shaft comprises
at least one fluid lumen.
41. The system of claim 39, wherein the multi-lumen shaft comprises
an expandable member connected to the multi-lumen shaft.
42. The system of claim 41, wherein the expandable member comprises
a balloon member.
43. The system of claim 42, wherein the multi-lumen shaft further
comprises a balloon inflation lumen.
44. The system of claim 31, wherein at least one viewing window is
located at a distal end of the miniscope lumen.
45. The system of claim 31, wherein at least one viewing window is
located at a side wall of the miniscope lumen.
46. The system of claim 31, wherein the elongate piercing member
comprises at least two viewing windows.
47. The system of claim 46, wherein at least two viewing windows
are serially arranged along a longitudinal length of the miniscope
lumen.
48. The system of claim 46, wherein at least two viewing windows
are serially arranged in parallel along a longitudinal length of
the miniscope lumen.
49. The system of claim 31, wherein the elongate piercing member
further comprises flexible segment.
50. The system of claim 49, wherein the elongate piercing member
further comprises a steering assembly configured to bend the
flexible segment.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims priority under 35 U.S.C.
.sctn.119(e) to U.S. Provisional Application No. 61/084,202 filed
on Jul. 28, 2008, the disclosure of which is hereby incorporated by
reference in their entirety.
BACKGROUND OF THE INVENTION
[0002] Injured intervertebral discs are generally treated with bed
rest, physical therapy, modified activities, and pain medications
for substantial treatment durations. There are also a number of
treatments that attempt to repair injured intervertebral discs and
to avoid surgical removal of injured discs. For example, disc
decompression is a procedure used to remove or shrink the nucleus,
thereby decompressing and decreasing the pressure on the annulus
and nerves. Less invasive procedures, such as microlumbar
discectomy and automated percutaneous lumbar discectomy, remove the
nucleus pulposus of a vertebral disc by aspiration through a needle
laterally inserted into the annulus. Another procedure involves
implanting a disc augmentation device in order to treat, delay, or
prevent disc degeneration. Augmentation refers to both (1) annulus
augmentation, which includes repair of a herniated disc, support of
a damaged annulus, and closure of an annular tear, and (2) nucleus
augmentation, which includes adding material to the nucleus. Many
conventional treatment devices and techniques, including open
surgical approaches, involve muscle dissection or percutaneous
procedures to pierce a portion of the disc under fluoroscopic
guidance, but without direct visualization. Several treatments also
attempt to reduce discogenic pain by injecting medicaments or by
lysing adhesions in the suspected injury area. However, these
devices also provide little in the form of tactile sensation for
the surgeon or allow the surgeon to atraumatically manipulate
surrounding tissue. In general, these conventional systems rely on
external visualization for the approach to the disc and thus lack
any sort of real time, on-board visualization capabilities.
[0003] Medication and physical therapy may be considered temporary
solutions for spine-related disorders. These therapies, however,
may not fully address the underlying pathologies. In contrast,
current surgical solutions such as laminectomy, where the laminae
(thin bony plates covering the spinal canal) are removed, permit
exposure and access to the nerve root which does address the
underlying pathologies. From there, bone fragments impinging the
nerves may be removed. Screws, interbody spacers, and fixation
plates may also be used to fuse or stabilize the spine following
laminectomy. These surgical techniques, however, are highly
invasive and often require extensive muscle dissection to achieve
adequate surgical exposure, which results in prolonged surgical
duration under general anesthesia and extended recovery periods.
Bone tissue is sometimes removed to improve surgical access, but
may also increase the risk of injury to nearby neurovascular
structures. Other surgical methods have been attempted, such as
laminotomy, which focuses on removing only certain portions or
smaller segments of the laminae.
[0004] Furthermore, accurately diagnosing back pain is often more
challenging than many people expect and may involve a combination
of a thorough patient history and physical examination, as well as
a battery of diagnostic tests. A major problem is the complexity of
the various components of the spine as well as the broad range of
physical symptoms experienced by individual patients. In addition,
the epidural space contains various elements such as fat,
connective tissue, lymphatics, arteries, veins, blood, and spinal
nerve roots. These anatomical structures make it difficult to treat
or diagnose conditions within the epidural area because they tend
to collapse around any instrument or device inserted therein. This
may reduce visibility in the epidural space, and may cause
inadvertent damage to nerve roots during device insertion. Also,
the insertion of a visualization device may result in blocked or
reduced viewing capabilities. As such, many anatomical elements
within the epidural space may limit the insertion, movement, and
viewing capabilities of any access, visualization, diagnostic, or
therapeutic device inserted into the epidural space.
BRIEF SUMMARY OF THE INVENTION
[0005] Systems and methods for accessing the spine include tissue
penetrating members with direct visualization capability that may
be used to form an access pathway to a targeted treatment site. The
direct visualization capability, which may be provided by
fiberoptic illumination and imaging components, may be use to
visualize the tissue as the access pathway is formed by the tissue
penetrating member. The tissue penetrating members include trocars,
catheters and cannulas with sharpened tips with integrated
fiberoptic components and/or channels in which a fiberscope or
miniscope may be inserted. Apertures and/or transparent materials
are provided to permit imaging of tissue about the distal end of
the tissue penetrating member.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] The invention is best understood from the following detailed
description when read in conjunction with the accompanying
drawings. It is emphasized that, according to common practice, the
various features of the drawings may or may not be to-scale. On the
contrary, the dimensions of the various features may be arbitrarily
expanded or reduced for clarity. Included in the drawings are the
following figures:
[0007] FIGS. 1A and 1B are perspective and side elevational views
of a fiberoptic scope;
[0008] FIGS. 2A and 2B are superior and side elevational views of a
tubular penetrating member with an inserted fiberoptic scope; FIG.
2C is a cut-away view of the tubular penetrating member in FIG.
2B;
[0009] FIGS. 3 to 5 depict various other embodiments of tubular
penetrating members;
[0010] FIGS. 6A and 6B are side and superior elevational views of a
tubular penetrating member comprising a blade;
[0011] FIGS. 7A and 7B are longitudinal cross-sectional views of a
multi-lumen penetrating member with an optional balloon in the
deflated and inflated states, respectively;
[0012] FIG. 8 is a longitudinal cross-sectional view of a
penetrating member with a transparent viewing balloon;
[0013] FIG. 9 is a side elevational view of a penetrating member
with a transparent viewing balloon and a transparent shaft
segment;
[0014] FIG. 10A is a perspective view of a penetrating member with
a balloon; FIG. 10B is a detailed view of the distal end of the
penetrating member in FIG. 10A; FIG. 10C is a cut-away view of the
penetrating member in FIG. 10A with a portion of the housing
removed;
[0015] FIG. 11 is a schematic perspective view of a portion of
lumbar vertebrae;
[0016] FIG. 12 is a schematic superior elevational view of a lumbar
vertebra;
[0017] FIG. 13 is a schematic side elevational view of lumbar
vertebrae;
[0018] FIGS. 14A and 14B are schematic side and superior
elevational views of a caudal spinal access procedure;
[0019] FIGS. 15A and 15B are schematic side and superior
elevational views of a postero-lateral spinal access procedure;
and
[0020] FIG. 16 is a schematic cross-sectional view of a vascular
access procedure.
DETAILED DESCRIPTION OF THE INVENTION
[0021] To reduce injury to the spine structures while preserving
the strength of the bones, minimally invasive spinal procedure have
been used to avoid excising native bone and/or dissection of
surrounding native tissues. Existing minimally invasive spinal
access procedures have been performed using both fluoroscopic
guidance and endoscopic visualization. While existing spinal
endoscopy systems provide direct vision capability to view the
treatment area in the spine or other areas of the body once it is
accessed, risks of iatrogenic injury to nerves and vessels, or
difficulty localizing the target site, often persist with these
systems. Similar risks and difficulties are associated with a
number of other minimally invasive and limited access procedures,
including but not limited to the placement of subclavian and
internal jugular catheters, renal biopsies, liver biopsies,
paracentesis, pleuracentesis, and femoral artery access, for
example.
[0022] The source of these risks may lie with the procedures used
to reach the treatment site. Before actual diagnostic or
interventional treatment can begin, the treatment site needs to be
accessed. This is typically performed without endoscopic
visualization, using a sharp-tipped guide wire, needle or trocar
under fluoroscopic or x-ray imaging. While detection of bone and
other calcified structures with fluoroscopy is relatively simple,
the detection of soft tissue structures with fluoroscopy remains
problematic, even with the injection of contrast agent(s). Thus,
during fluoroscopic procedures, soft tissue structures proximate to
the treatment site, such as the nerves and blood vessels, are at
significant risk of accidental injury. Excessive use of fluoroscopy
and other indirect imaging systems may also subject both patients
and healthcare workers to long-term risks associated with ionizing
radiation.
[0023] However, by providing direct or local visualization during
the initial access phase of an invasive procedure, rather than
after the target site has been reached, further improvements in
safety may be achieved. This may be performed, for example, by
providing an instrument, such as a guidewire, cannula or trocar,
with a penetrating tip and a direct visualization system to view
the body tissue as the penetrating tip is cutting or piercing
through intact tissue to reach the target site. The target site may
be solid tissue site, such as a breast mass, the wall or lumen of a
body structure, or the potential or actual space of a body cavity,
for example. By visualizing body tissue while achieving access to a
target site, the access instrument may be reoriented if certain
structures or tissues are visualized.
[0024] FIGS. 1A and 1B depicts one embodiment of a fiberoptic scope
2 that may be inserted into a patient to optically visualize
tissues and structures. The scope 2 comprises a proximal housing 4
which is used to receive the visual images from the distal end 6 of
the scope 2, and to optionally transmit illumination to the distal
end 6. In this particular embodiment, the proximal housing 4
comprises an eyepiece 8 that may be used to view the optical images
transmitted from the distal end 6 of the scope 2, as well as a
connector 10 that may be used to couple the scope 2 to a video
monitor and/or an illumination system. In other examples, the scope
may have only the eyepiece, only the monitor/illumination coupling,
or separate couplings for the monitor and illumination. The
proximal housing 4 may be connected to a shaft assembly 12, which
comprises a proximal shaft segment 14, a distal shaft segment 16
and an optional handle 18. There may or may not be a visible
delineation between the proximal and distal shaft segments, and in
some examples, the proximal and distal shaft segments may be
opposite ends of a continuous shaft body. Although the depicted
shaft assembly 12 In some examples, the distal shaft segment 16 may
have a diameter or average transverse axial dimension in the range
of about 0.5 mm to about 1.5 mm or more, sometimes about 0.7 mm to
about 1.2 mm, and other times about 0.8 mm to about 1 mm. The
length of the distal shaft segment 16 may be in the range of about
30 mm to about 1 meter or more, sometimes about 200 mm to about 600
mm, and other times about 300 mm to about 500 mm. The proximal
housing 4 and/or the handle 18 may comprise molding, gripping
materials and/or surface texturing to augment the gripping
characteristics of the scope 2. For example, in FIG. 1A, the
optional handle 18 comprises a knurled surface 20.
[0025] The flexibility or rigidity of the various segments of the
shaft assembly 12 may vary or may be uniform. For example, the
proximal shaft segment 14 and the handle 18 in FIGS. 1A and 1B may
be rigid and comprise a material such as stainless steel, while the
distal shaft segment 16 may comprise a flexible material such as
polyimide. In examples where the shaft assembly has a flexible
distal region, the scope may be inserted into steerable or other
bendable instruments to permit visualization along a non-linear
axis. In some embodiments, the proximal housing or the shaft
assembly may comprise one or more connectors or interfaces to
couple the scope to other instruments such as a multi-lumen
cannula. These interfaces may include any of a variety of threaded
interfaces or releasable lock interfaces, for example. The shaft
assembly 12 comprises at least one visualization optic fiber, if
not multiple optic fibers, to transmit the optical information from
the distal end 6 of the scope 2 to the proximal housing 4, and may
optionally comprise one or more illumination fibers to transmit
light to the distal end 6. In other embodiments, an illumination
source may be provided at the distal end, with electrical lines or
traces provided to power the illumination source. The distal shaft
segment 16 may also optionally comprise one or more lenses which
may be use to focus the images and/or the illumination. The
particular arrangement of the visualization fibers, the optional
illumination fibers and the optional lenses may vary, and may
affect the viewing angle 22 of the scope 2. In some embodiments,
the viewing angle of the scope may be in the range of about 10
degrees to about 180 degrees, or about 45 degrees to about 135
degrees, and other times about 90 degrees to about 120 degrees.
Although the viewing angle 20 schematically depicted in FIG. 1A is
depicted as symmetrically aligned with respect to the longitudinal
axis of the scope 2, in other examples, the viewing angle may be
offset from the longitudinal axis of the distal shaft segment
16.
[0026] Other scopes that may be used are disclosed in U.S. Pat.
Nos. 4,807,597 and 4,899,732, which are hereby incorporated by
reference in their entirety, as well as various scopes made by
Vision-Sciences (Rangeburg, N.Y.). In other embodiments, the
visualization instrument may comprise a different local
visualization system, such as an ultrasound imaging device that is
insertable into the body using a minimally invasive procedure, such
as the intravascular ultrasound systems used to visualize vascular
plaques and biliary trees, for example.
[0027] The scope 2 in FIGS. 1A and 1B may be inserted into an
access system which is configured with one or more regions that
permits viewing of the surroundings about the cutting or piercing
structure used to form the access pathway. In FIGS. 1A to 1C, for
example, the access system may comprise a tubular penetrating
member 30 with a distal piercing tip 32 and at least one inner
lumen 34 configured to receive the scope 2. In some alternate
embodiments, one or more subcomponents of the scope may be
integrated into the tubular penetrating member or provided in a
separate device to be inserted into a different lumen. For example,
in some embodiments, the scope may lack the illumination fibers,
which may be provided instead in the tubular penetrating member
along with an illumination connector. In this particular example,
providing illumination from a different location than the distal
end scope may improve the viewing the tissue surrounding the distal
piercing tip or other regions of the tubular penetrating member. In
some further embodiments, the tubular penetrating member and the
scope may also be integrally formed. In still other embodiments,
the scope and/or tubular penetrating member may comprise one or
more additional lumens which may be used, for example, for
irrigation, therapy, dye or imaging agent delivery, or guidewire
insertion.
[0028] The inner lumen 34 of the tubular penetrating member 30 may
comprise one or more side openings 36 and 38 to permit
visualization of the surroundings from the lumen 34. In this
particular example, the side openings 36 and 38 are uncovered, but
in other embodiments disclosed herein, one or more openings may be
covered with a transparent material. As shown in FIGS. 1B and 1C,
the inner lumen 34 and the side openings 36 and 38 may be
configured so that the distal segment 16 and/or the distal end 6 of
the scope 2 may protrude from at least one of the side openings 36
and 38. In this particular embodiment, the side openings 36 and 38
have oval configurations that are oriented along their longer
dimensions with the longitudinal axis of the tubular penetrating
member 30. The side openings may have a longitudinal length that
may be in the range of about 0.4 mm to about 10 mm or more,
sometimes about 0.6 mm to about 3 mm, and other times about 0.8 mm
to about 2 mm. The openings 36 and 38 may have a width of about 0.4
mm to about 1.5 mm or more, sometimes about 0.6 mm to about 1.2 mm,
and other times about 0.7 mm to about 0.9 mm. Although the side
openings 36 and 38 are depicted as symmetrically spaced about 180
degrees apart along the circumference of the tubular penetrating
member 30, and are longitudinally aligned, the openings may also be
asymmetrically spaced around the circumference and a number of
openings may be provided along the longitudinal length in or out of
alignment. The distance between the most distal side openings and
the distal point 40 of the piercing tip 32 may be in the range of
about 0.5 mm to about 20 mm or more, sometimes about 0.8 mm to
about 5 mm, and other times about 0.8 mm to about 2 mm.
[0029] Referring to FIG. 2C, although the proximal section 44 of
the tubular penetrating member 30 comprises only the proximal
opening 46 of the inner lumen 34, in other embodiments the proximal
section may optionally comprise a handle, a housing or some other
configuration. In some specific examples, the proximal opening of
the inner lumen may have a flared configuration to facilitate the
insertion of the scope 2 into the tubular penetrating member. In
other embodiments, however, the scope may be inserted into the
tubular penetrating member during manufacturing and configurations
to facilitate insertion are not provided.
[0030] As mentioned previously, in some embodiments, the side
openings may be covered with a transparent material. In FIG. 3, for
example, the tubular penetrating member 50 has openings 52 that are
covered by transparent windows 54. The transparent window material
may be an optically transparent material, including various forms
of glass, nylon, Pebax, PET, FEP, PTFE, polyolefin, acrylic,
polycarbonate or polyethylene, for example. In other embodiments
where the visualization instrument is a non-optical device (e.g.
ultrasound), the transparent window may transparent to the
particular imaging modality but not to others.
[0031] Although the distal piercing tip 32 depicted in FIGS. 2A to
2C has a conical configuration and a distal point 40 that is
centrally located, in other examples, the distal piercing tip may
have an eccentrically located distal point, multiple distal points,
or a non-conical configuration. The distal point 40 may be sharp or
may be blunt. Also, the angle 42 of the distal piercing tip 32 may
be different, and may be in the range of about 10 degrees to about
175 degrees, sometimes about 35 degrees to about 120 degrees, and
other times about 45 degrees to about 90 degrees, for example.
[0032] In FIG. 4, for example, the tubular penetrating member 60
comprises a distal piercing tip 62 that has a pyramidal
configuration with one or more edges 64, 66 and 68. In this
example, the edges 64, 66 and 68 are linear and span the distance
from the distal point 70 to the base 72 of the distal piercing tip
62. The each of the edges 64, 66 and 68 may be sharp or blunt. In
other embodiments, the edges may be span less than the full length
of the distal piercing tip, and may have a non-linear
configuration. Some non-linear configurations may include helical
configurations, angular configurations, and concentric
configurations, for example. As further shown in FIG. 4, the
tubular penetrating member 60 comprises a distal viewing region 74
a number of rectangular openings 76 separated by struts 78 which
connect the distal shaft segment 80 with the distal piercing tip
62. FIG. 5 depicts another example of a tubular piercing member 90
wherein the viewing region 92 comprises a transparent tube 94 or
cylinder connecting the distal shaft segment 96 with the distal
piercing tip 98. Also, the distal piercing tip 98 also comprises a
transparent material.
[0033] FIGS. 6A and 6B depict another embodiment of a tubular
penetrating member 200, comprising a distal viewing region 202 with
one or more side openings 204 and 206, along with a distal piercing
tip 208 with a protruding blade 210 or other piercing
configuration. Although a single blade is illustrated in FIGS. 6A
and 6B, in other examples, multiple blades may be provided. Also,
the blade 210 may have a triangular configuration as depicted, but
may have other configurations, such as a spade configuration, a
square or rounded spatula configuration, or any of a variety of
other blade configurations. The blade orientation relative to the
distal viewing region or the openings may also vary. In FIGS. 6A
and 6B, for example, the single blade 210 is located in a plane
that lies symmetrically in the middle of each opening 204 and 206,
but in other embodiments, the blade may be located in a plane that
lies symmetrically between the openings, or a plane that is offset
or angled with respect to the central longitudinal axis of the
tubular penetrating member.
[0034] As mentioned previously, some embodiments of the penetrating
member may comprise a multi-lumen configuration. In FIGS. 7A and
7B, for example, the penetrating member 220 comprises a scope lumen
222 for the insertion of a fiberoptic scope. The scope lumen 222
may be used to provide visualization through the transparent
piercing tip 224 of the penetrating member 220. The penetrating
member may also comprise an accessory lumen 226 that may be used
for any of a variety of functions. In the particular configuration
in FIGS. 7A and 7B, the accessory lumen 226 has a distal lumen 230
that continues through the transparent piercing tip 224. The
transparent piecing tip 224 in this example comprises a beveled
configuration that provides a large planar surface 228. In some
instances, the large planar surface 228 may improve the viewing
through transparent materials compared to multiple smaller angled
surfaces. Although the scope lumen 222 has a generally linear
configuration which is not at a perpendicular angle to the large
planar surface 228, in some embodiments the scope lumen may be
angled closer to a perpendicular angle to the large planar surface
228, or any other viewing surface.
[0035] The penetrating member 220 in FIGS. 7A and 7B further
comprises an optional balloon 232. The balloon 232 may be bonded to
the shaft 234 of the penetrating member 220 to form a balloon
cavity 236 which may be inflated by an inflation lumen 238 of the
shaft 234 at an inflation opening 240. The balloon 232 may be
inflated with a gas or a liquid, such as saline. In some instances,
the balloon 232 may be used during an access procedure to enlarge
the access pathway to push away the tissue surrounding the
penetrating member 220, which may improve the visualization and
identification of the tissue, and may also dilate the pathway to
permit passage of larger instruments.
[0036] The balloon 232 may comprise any of a variety of stretchable
and non-stretchable medical balloon materials, including but not
limited to polyurethane or PET, for example. The balloon assembly
230 may have any of a variety of shapes upon inflation, including
but not limited to a cylindrical, conical, spherical, elliptical,
tapered or stepped configuration for example. The balloon 232 in
FIG. 7B has an inflated toroidal shape that is symmetrically
arranged about the circumference of the shaft 234, but in other
embodiments, the balloon shape may be offset of eccentrically
arranged with respect to the shaft. In the uninflated state, the
balloon 232 may have an outer diameter of about 4 mm or less,
sometimes about 3.6 mm or less, and other times about 3 mm or less.
In the inflated state, the balloon 232 may have a maximum outer
diameter of about 4 mm or more, sometimes about 5 mm or more, and
other times about 6 mm or more. The longitudinal length of the
balloon 232, as mounted on the shaft 234, may be in the range of
about 3 mm to about 20 mm, sometimes about 4 mm to about 10 mm, and
other times about 5 mm to about 8 mm, for example.
[0037] The balloon 232 may be attached to the shaft 234 by
adhesives or by heat bonding, for example. In some embodiments,
attachment structures or processes may be used, which improve the
sealing between the balloon and the tubular shaft to support the
use of higher inflation pressures without separating the balloon
from the tubular shaft. For example, crimp rings or heat shrink
tubing may be used to augment the bonding or attachment process.
The crimp rings or shrink tubing may be applied temporarily to
facilitate setting of other bonding processes. In other
embodiments, the crimp rings or shrink tubing may be incorporated
into the final assembled product.
[0038] In some embodiments, the side openings of the penetrating
member may be configured so that the visualization occurs through
the balloon and the balloon cavity. This may permit the user to
selectively adjust the distance of any abutting tissue by
selectively inflating or deflating the balloon. In FIG. 8, for
example, the penetrating member 250 comprises a distal blade 252
and a viewing region 254 with two side openings 256 and 258. The
side openings 256 and 258 are in communication with the balloon
cavity 260 of a balloon 262 that a sealed around the openings 256
and 258. Here the inner lumen 264 of the penetrating member 250 is
configured to receive a scope, but to also inflate and deflate the
balloon cavity 260. The scope used with this particular penetrating
member 250 may be configured to withstand the pressure to which the
balloon 262 may be inflated. FIG. 9 depicts another embodiment of a
penetrating member 270, comprising a conical penetrating tip 272, a
transparent inflatable balloon 274 and a transparent shaft 276. In
some instances, a transparent shaft may permit the visualization of
the tissues and structures along the entire access pathway, not
just the region surrounding the distal end of the penetrating
member 270.
[0039] FIGS. 10A and 10B are general and detailed views of one
embodiment of a balloon penetrating member 300, comprising a
tubular shaft 302 with a proximal end 304 and a distal end 306. The
proximal end 304 of the penetrating member 300 is attached to an
optional housing 318, while the distal end 306 comprises an
inflatable balloon 316 and a penetrating tip 317. Various ports
308, 310, 312, and 314 may be optionally provided on the shaft or
the optional housing 318, and may be configured for any of a
variety of usages, including but not limited to
infusion/drainage/suction of fluids or materials, insertion/removal
or supporting an endoscope or fiber-optic device,
inflation/deflation of the inflatable balloon 316, and for
insertion/removal or support of other instruments or tools. The
housing 318 may also an optional steering mechanism 320.
[0040] The steering mechanism 320 may be configured to cause
bending of the shaft 302 at one or more bending regions 324. In
FIG. 10C, the steering mechanism 320 is depicted with the port
tubing and a portion of the housing 318 removed. The steering
mechanism 320 comprises a lever 322 that is configured to rotate or
pivot at a lever axle 390. In other embodiments, the steering
mechanism 320 may comprise a slide, knob or other configuration.
The lever 322 is attached to two control members 392 that are
slidable located along the length of the shaft 302 and are attached
at a distal location of the shaft 302. The movement range and force
may be augmented by one or more bias members 398 acting upon the
lever 322. The bias members 198 may comprise helical springs as
depicted in FIG. 10C, but may also comprise leaf springs or any
other type of bias member configuration. The movement range of the
lever 322 may also be affected by the size and/or configuration of
the lever openings 399 provided in the housing 318. In some
embodiments, an optional locking mechanism may be provided to
substantially maintain the lever in one or more positions.
[0041] The control members 392 may comprise wires, threads, ribbons
or other elongate structures. The flexibility and/or stiffness of
the control member 392 may vary depending upon the particular
steering mechanism. In further embodiments, the characteristics of
the control member 392 may also vary along its length. In
embodiments comprising two or more control members, the control
members need not be configured symmetrically, e.g. having the same
length, cross-sectional area or shape, or opposite attachment sites
with respect to the longitudinal axis of the tubular shaft. Also,
individual control members need not have the same configuration
along their lengths.
[0042] The bending range of bending regions 324 may vary. The
balloon penetrating member 300 may be configured with a one-sided
or a two-sided bending range with respect to the neutral position
of the shaft. The bending range may be in the range of about 0
degrees to about 135 degrees, sometimes from about 0 degrees to
about 90 degrees, and other times about 0 degrees to about 45
degrees, and still other times about 0 degrees to about 15 or about
20 degrees. The bending range of the other side, if any, may be
less than, equal to, or greater than the first side.
[0043] As mentioned previously, a penetrating member with direct
visualization capabilities may be used for a variety of medical
procedures in a variety of fields. A penetrating member with a
scope may be used to provide the initial access to a particular
target site that would otherwise be performed blindly, under
fluoroscopy, or using external imaging modalities. In one
particular example, a penetrating member may be used to provide
access to the epidural or paravertebral region of the cervical,
thoracic or lumbar spine. One access to the region is achieved,
endoscopic instruments may be positioned using the access pathway
to accomplish a variety of spinal procedures, including lysis of
adhesions, anesthetic injections, nucleotomy, discectomy and
foraminotomy, and laminectomy, for example. Some examples are
described below.
[0044] FIGS. 11 to 13 are schematic views of a lumbar region of a
spine 100. The vertebral canal 102 is formed by a plurality of
vertebrae 104, 106, and 108, which comprise vertebral bodies 110,
112 and 114 anteriorly and vertebral arches 116 and 118
posteriorly. The vertebral arch and adjacent connective tissue of
the superior vertebra 104 has been omitted in FIG. 11 to better
illustrate the spinal cord 122 within the vertebral canal 102.
Spinal nerves 124 branch from the spinal cord 122 bilaterally and
exit the vertebral canal 102 through intervertebral foramina 126
(seen best in FIGS. 12 and 13) that are formed by the adjacent
vertebra 104, 106 and 108. The intervertebral foramina 126 are
typically bordered by the inferior surface of the pedicles 120, a
portion of the vertebral bodies 104, 106 and 108, the inferior
articular processes 128, and the superior articular processes 130
of the adjacent vertebrae. Also projecting from the vertebral
arches 116 and 118 are the transverse processes 132 and the
posterior spinous processes 134 of the vertebrae 106 and 108.
Located between the vertebral bodies 110, 112 and 114 are the
vertebral discs 132.
[0045] Referring to FIG. 12, the spinal cord 122 is covered by a
thecal sac 136. The space between the thecal sac 136 and the
borders of the vertebral canal 102 is known as the epidural space
138. The epidural space 138 is bound anteriorly and posteriorly by
the longitudinal ligament 140 and the ligamentum flavum 142 of the
vertebral canal 102, respectively, and laterally by the pedicles
120 of the vertebral arches 116 and 118 and the intervertebral
foramina 126. The epidural space 138 is contiguous with the
paravertebral space 144 via the intervertebral foramina 126.
[0046] With this anatomical framework, a number of exemplary access
procedures may be performed. The particular access procedure may
depend on the suspected diagnosis and/or the likely treatment to be
performed. For example, FIGS. 14A and 14B schematically depict a
midline spinal access procedure using a penetrating member 500 that
forms an access pathway between two adjacent vertebrae 502 and 504,
which may be used to access the central spinal canal and epidural
space of a patient. Such procedures have been used, for example, to
provide epidural anesthesia but, intravascular injection of the
anesthesia or other injuries have occurred due to inaccurate needle
placement.
[0047] To perform an epidural access procedure using a penetrating
member with a direct visualization feature, the patient may be
placed in a sitting or lateral decubitus position with the spine
arched anteriorly. The target level along the spine is identified
using surface landmarks or other indicia and the skin is prepped
and draped. Local anesthesia is achieved in the skin region. The
penetrating member 500 with a scope is inserted into the skin
tissue 506 until the ligamentous tissue of the interspinous
ligament is visualized and monitored until the tip of the
penetrating member 500 passes out of the anterior surface of the
ligament and into the epidural space 508 In some embodiments, the
scope may be removed from the penetrating member 500 while holding
the penetrating member 500 in position, and a guidewire may be
inserted through the penetrating member and into the epidural
space. The penetrating member 500 may then be removed and a dilator
may be optionally inserted and withdrawn over the guidewire. An
introducer is then optionally placed over the guidewire and the
guidewire is then optionally removed. An endoscope or other tubular
instrument with a miniscope or fiberscope is then inserted through
the introducer and/or over the guidewire to revisualize the
epidural space. In some instances, the miniscope or fiberscope
withdrawn from the penetrating member may be inserted into the
endoscope and tubular instrument to provide visualization.
[0048] In another procedure, access to an intervertebral foramen is
achieved using a penetrating member with direct visualization. In
this procedure, the patient is placed in a prone position. The
target site is identified and the skin is prepped and draped.
Referring to FIGS. 15A and 15B, Anesthesia is achieved and a
penetrating member 520 with a scope is inserted into the skin
tissue 522 at a location about 10 cm from the midline. The
penetrating member 520 may be angled at the skin tissue 522 to
about a 35 degree angle to the midsaggital plane, or may be steered
midline after at least partially penetrating the skin tissue 522.
After partial penetration of the skin tissue, the penetrating
member 520 s steered toward the midline to avoid interference from
the spinous processes 524 of the vertebrae 526 and/or to achieve a
particular access angle upon reaching the target site. The tissue
around the piercing tip 528 of the penetrating member 520 is
visualized as the penetrating tip 524 is piercing intact body
tissue, watching for the penetrating tip 524 to emerge from the
body tissue and into the paravertebral space 530 adjacent to the
foramen 532. The insertion of the penetrating member then stopped
to avoid inadvertent damage to the nerves located in the
intervertebral foramen and the penetrating member 520 is exchanged
for other therapeutic or diagnostic instruments.
[0049] The penetrating members described herein may be used for any
of a variety of access procedures. In some examples, a penetrating
member may be inserted through the chest wall and visualization is
used to determine when the pleural cavity filled with pleural fluid
is reached, thereby reducing the risk of puncturing the lung and
causing a pneumothorax. In another example, a penetrating member
may be inserted through the abdominal wall and visualization is
used to determine when the abdominal cavity is reached, thereby
reducing the risk of perforating other abdominal organs such as the
liver or the bowel.
[0050] In addition to reducing the risk of inadvertent puncture or
damage to adjacent structures, the penetrating member with direct
visualization capabilities may be used to identify various body
structures that may be difficult to determine by indirect or
external imaging, tactile response, or other surrogate measures.
For example, venous and arterial access may be challenging for a
number of reasons, such as a volume-depleted patient due to blood
loss or dehydration, or when access was initially achieved but
further insertion of the access instrument resulted in puncture
through the distal lumen surface and out of the target site, or is
dissecting along a wall of the artery. In FIG. 16, for example, a
penetrating member 540 with a scope is inserted into the groin
region of a patient achieve femoral artery access. The piercing tip
542 of the penetrating member 540 is inserted through the skin
layers 544 and 546, and then through the underlying connective
tissue 548. The tissue surrounding the piercing tip 542 is
visualized as the penetrating member 540 is inserted, looking for a
blood flash indicative of entering the artery 550, but also
checking whether the femoral vein was accessed, or whether the
penetrating member 540 has passed next to any adjacent structures.
When this occurs, the penetrating member 540 may be partially
withdrawn and redirected toward the target site, based upon the
landmarks visualized from the penetrating member 540.
[0051] It is to be understood that this invention is not limited to
particular exemplary embodiments described, as such may, of course,
vary. It is also to be understood that the terminology used herein
is for the purpose of describing particular embodiments only, and
is not intended to be limiting, since the scope of the present
invention will be limited only by the appended claims.
[0052] Where a range of values is provided, it is understood that
each intervening value, to the tenth of the unit of the lower limit
unless the context clearly dictates otherwise, between the upper
and lower limits of that range is also specifically disclosed. Each
smaller range between any stated value or intervening value in a
stated range and any other stated or intervening value in that
stated range is encompassed within the invention. The upper and
lower limits of these smaller ranges may independently be included
or excluded in the range, and each range where either, neither or
both limits are included in the smaller ranges is also encompassed
within the invention, subject to any specifically excluded limit in
the stated range. Where the stated range includes one or both of
the limits, ranges excluding either or both of those included
limits are also included in the invention.
[0053] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this invention belongs. Although
any methods and materials similar or equivalent to those described
herein can be used in the practice or testing of the present
invention, some potential and preferred methods and materials are
now described. All publications mentioned herein are incorporated
herein by reference to disclose and describe the methods and/or
materials in connection with which the publications are cited. It
is understood that the present disclosure supersedes any disclosure
of an incorporated publication to the extent there is a
contradiction.
[0054] It must be noted that as used herein and in the appended
claims, the singular forms "a", "an", and "the" include plural
referents unless the context clearly dictates otherwise. Thus, for
example, reference to "a blade" includes a plurality of such blades
and reference to "the energy source" includes reference to one or
more sources of energy and equivalents thereof known to those
skilled in the art, and so forth.
[0055] The publications discussed herein are provided solely for
their disclosure. Nothing herein is to be construed as an admission
that the present invention is not entitled to antedate such
publication by virtue of prior invention. Further, the dates of
publication provided, if any, may be different from the actual
publication dates which may need to be independently confirmed.
[0056] The preceding merely illustrates the principles of the
invention. It will be appreciated that those skilled in the art
will be able to devise various arrangements which, although not
explicitly described or shown herein, embody the principles of the
invention and are included within its spirit and scope.
Furthermore, all examples and conditional language recited herein
are principally intended to aid the reader in understanding the
principles of the invention and the concepts contributed by the
inventors to furthering the art, and are to be construed as being
without limitation to such specifically recited examples and
conditions. Moreover, all statements herein reciting principles,
aspects, and embodiments of the invention as well as specific
examples thereof, are intended to encompass both structural and
functional equivalents thereof. Additionally, it is intended that
such equivalents include both currently known equivalents and
equivalents developed in the future, i.e., any elements developed
that perform the same function, regardless of structure. The scope
of the present invention, therefore, is not intended to be limited
to the exemplary embodiments shown and described herein. Rather,
the scope and spirit of present invention is embodied by the
appended claims. For all the embodiments described herein, the
steps of the method need not be performed sequentially.
* * * * *